Alcohol Use Disorder, Cardiovascular Disease, HIV Risk, Substance Use Disorders
Conditions
Brief summary
The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.
Interventions
BEHAVIORALNavigation, compensation, and personalization
The study intervention is composed of navigation, compensation, and personalization. Navigation refers to reducing barriers posed by fragmentation of health and social systems. Compensation refers to reimbursement of out-of-pocket expenses to offset dependent care, time costs, and travel expenditures necessary to access care for the different conditions and goals of the intervention. Personalization refers to preventative interventions that are personalized based on individual for potential benefit.
Sponsors
NYU Langone Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 35 to 64 2. Low SES (≤ $38,000 annual income, based on 2019 20th percentile NYC income, adjusted for family size) 3. Expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors: 1. 10-year cardiovascular risk ≥10% (assessed by ASCVD risk tool) 2. Heavy alcohol consumption (defined using SAMHSA binge drinking definition, drinking \>4 standard drinks for men and \>3 standard drinks for women on same occasion in past month) 4. Willing to be navigated to Health and Hospitals Corporation of New York health system. 5. Ability to provide written informed consent in English or Spanish
Exclusion criteria
1. Receives regular care elsewhere than Health and Hospitals Corporation of New York 2. Already diagnosed with high mortality-condition(s) that are not included in the simulation model.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use Disorders Identification Test (AUDIT) Score | Baseline, Month 12 | 10-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-40; higher scores indicate it is more likely the patient's drinking is affecting their health and safety. |
| Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) | Baseline, Month 12 | 4-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-12; higher scores indicate it is more likely the patient's drinking is affecting their health and safety. |
| Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1) | Baseline, Month 12 | The NIAAA-1 asks participants how many times in the past year they have had four or more drinks (for females) or five or more drinks (for males) in a day. The responses are 0 (never), 1 (Less than once a month), 2 (One to three times per month), 3 (One to three times per week) and 4 (More than three times per week). The total score is the item response and ranges from 0-4; higher scores indicate greater unhealthy alcohol use. |
| Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use | Baseline, Month 12 | The TLFB allows participants to indicate how many drinks they have had over the previous two weeks. |
| Change in Ethanol Glucuronide (ETG) Levels | Baseline, Month 12 | ETG (ng/ml) will be measured via urine test. |
| Change in Phosphatidylethanol (PeTH) Levels | Baseline, Month 12 | PeTH (ng/ml) will be measured via blood test. |
| Change in CDC HIV Incidence Risk Index Score | Baseline, Month 12 | 3-item assessment of HIV risk among people who inject drugs. The total score ranges from 0 to 100; higher scores indicate greater risk of HIV. |
| Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score | Baseline, Month 12 | The AHA/ACC Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator is a questionnaire that uses responses to calculate the lifetime risk of ASCVD as a percentage (0%-100%); higher percentages indicate greater lifetime risk of ASCVD. The percentages are classified as follows: * Low-risk (\<5%) * Borderline risk (5% to 7.4%) * Intermediate risk (7.5% to 19.9%) * High risk (≥20%) |
| Mean Systolic Blood Pressure | Up to Month 12 | — |
| Mean Diastolic Blood Pressure | Up to Month 12 | — |
| Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool | Baseline, Month 12 | The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool is used to assess primary care patients for tobacco, alcohol, prescription drug, and illicit substance use and problems related to their use. Based on patient responses, the tool classifies the patient risk levels as "High Risk," "Problem Use," "Undetermined Risk" and "Minimal Risk." This outcome measures the percent change in participants determined to be "High Risk" for substance abuse disorder (SUD) from baseline to Month 12. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRonald S Braithwaite, Braithwaite
NYU Langone Health
Outcome results
None listed